Abstract
Objective: This prospective, randomized study compared the efficacy of the HemConTM pad to that of manual compression for peripheral artery puncture in peripheral artery disease. Methods: This study was a prospective single center, investigation in 50 consecutive patients undergoing interventional procedures for peripheral artery disease. After completion of catheter procedure a 1:1 randomization to HemConTM pad versus conventional manually pressure (control) was performed. Before the removal of the artery sheath (4 to 6Fr), a blood examination was taken for activated clotting time (ACT). The femoral sheath was removed at the patient’s bed immediately after the procedure. Slightly blood was allowed to exit from the access site and pressure with HemConTM pad or directory was then applied manually for 2×ACT seconds. After the time the operator released the compression. If the bleeding continued, additional compression was continued until complete hemostasis. Before and after hemostasis blood pressure and the total time to hemostasis were recorded. We checked puncture site and performed ultra sound detecting abnormality before discharge. Results: We have successful hemostasis in 48 of 50 patients (96% success); two patients had been converted into over size sheath (10Fr) during catheter procedure. The average time to successful hemostasis following sheath removal was significant shorter with the HemConTM pad by 53% compared to the conventional manual compression (681 ± 243 vs. 362 ± 82 seconds, p<0.001). In duplex ultrasound examination, there were no thromboses in access site artery. Conclusion: The HemConTM pad is effective at decreasing average time to hemostasis. This device may save the time for physician and the cost for hospital. Furthermore, this device can contribute to patient comfort, reduce the time to compression, and promise to a planned discharge.
Highlights
Many peripheral artery diseases are performed via peripheral artery
There were no significant differences in patient’s characteristics (Table 1). 29 cases were sealed in the femoral artery, and 19 cases were in the brachial artery
This study showed no difference between the two groups in procedure time, pre blood pressure and activated clotting time (ACT) just before sheath removal (Table 2)
Summary
Many peripheral artery diseases are performed via peripheral artery. Hemostasis of artery is performed by applying local pressure either manually for femoral artery or by mechanical devices for brachial artery. Vascular complications requiring surgical repairing may be seen in 1 to 5% of patients undergoing interventional procedures [1,2]. The HemConTM pad (HemConTM Medical Technologies, Inc., Portland, OR, USA) is used armies to control traumatic bleeding in many countries. It consists of carbohydrate called chitosan produced by deacetylation of chitin, which is extracted from crustaceans. We describe here our experiences to evaluate the performance of HemConTM pad device for hemostasis after percutaneous transluminal angioplasty for peripheral artery disease
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